Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Other: RibomustinOther: rituximab
- Registration Number
- NCT02072967
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the second line therapy of relapsed or refractory indolent B-cell non-Hodgkin's lymphoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
- Doctor's decision to prescribe Ribomustin and rituximab combined therapy for the treatment of relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
- Informed Consent Form for personal data handling signed by the program participant, authorized by the Independent Ethics Committee
- Eastern Cooperative Oncology Group (ECOG) status < 2.
- Confirmed relapse or disease progression of B-cell CD20+ Non-Hodgkin's Lymphoma (lymphocytic, lymphocytoplasmocytic, follicular, marginal zone) after minimum one line of iNHL treatment
- Patients with relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma with current or planned Ribomustin and rituximab combined therapy with following rituximab maintenance therapy
- Indolent Non-Hodgkin's Lymphoma transformation
- Lymphoma with central nervous system (CNS) involvement
- Presence of second malignant tumor.
- Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment.
- Contraindications for Ribomustin usage in accordance with product label
- Contradictions for rituximab usage in accordance with product label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ribomustin and rituximab Ribomustin - Ribomustin and rituximab rituximab -
- Primary Outcome Measures
Name Time Method Overall response rate 90 days post-treatment
- Secondary Outcome Measures
Name Time Method Adverse drug reactions up to 1 year
Trial Locations
- Locations (35)
City Clinical Hospital #8
🇷🇺Barnaul, Russian Federation
Chelyabinsk Regional Oncology Dispensary/15
🇷🇺Chelyabinsk, Russian Federation
Vologda Regional Clinical Hospital #2
🇷🇺Cherepovets, Russian Federation
Regional Oncology Dispensary/35
🇷🇺Irkutsk, Russian Federation
Irkutsk Regional Сlinical Hospital/31
🇷🇺Irkutsk, Russian Federation
Kaluga Regional Clinical Hospital/02
🇷🇺Kaluga, Russian Federation
City Сlinical Hospital#7/25
🇷🇺Krasnoyarsk, Russian Federation
District Cancer center od Khanty -Mansiysk
🇷🇺Khanty-Mansiysk, Russian Federation
Adygei Regional Clinical Oncology Dispensary/11
🇷🇺Maykop, Russian Federation
Regional Сlinical Hospital/12
🇷🇺Krasnoyarsk, Russian Federation
European Medical Center
🇷🇺Moscow, Russian Federation
Scientific Medical Surgical Center n.a.I.V.Pyrogov/17
🇷🇺Moscow, Russian Federation
RONC n.a.N.N.Blokhin/18
🇷🇺Moscow, Russian Federation
Сentral Clinical Hospital n.a. Semashko N.A./30
🇷🇺Moscow, Russian Federation
Moscow Scientific Research Oncology Institution n.a.P.A. Gertzen/37
🇷🇺Moscow, Russian Federation
Central Clinical Hospital of Department of Presidential Affairs
🇷🇺Moscow, Russian Federation
Omsk Regional Clinical Hospital/40
🇷🇺Omsk, Russian Federation
Medical Radiology Scientific Center/38
🇷🇺Obninsk, Russian Federation
Novosibirsk State Regional Clinical Hospital/23
🇷🇺Novosibirsk, Russian Federation
Municipal Сlinical Hospital № 12/20
🇷🇺Nizhniy Novgorod, Russian Federation
Rostov Scientific Research Oncology Institution/01
🇷🇺Rostov-on-Don, Russian Federation
City Сlinical Hospital#1 n.a.Kabanov A.N./13
🇷🇺Omsk, Russian Federation
Orenburg State Medical Academy/05
🇷🇺Orenburg, Russian Federation
City Сlinical Oncological Dispensary/22
🇷🇺Saint-Petersburg, Russian Federation
City Сlinical Hospital#31/08
🇷🇺Saint-Petersburg, Russian Federation
Military-Medical Academy n.a. Kirova
🇷🇺Saint-Petersburg, Russian Federation
Samara State Medical University' Clinics/36
🇷🇺Samara, Russian Federation
Scientific Research Oncological Institution n.a. Petrov N.N./29
🇷🇺Saint-Petersburg, Russian Federation
Road Clinical Hospital on Rostov-Main Station OAO RZhD/06
🇷🇺Smolensk, Russian Federation
Surgut Regional Clinical Hospital
🇷🇺Surgut, Russian Federation
Volgograd Regional Clinical Oncology Dispensary#1/10
🇷🇺Volgograd, Russian Federation
Vologda Regional Clinical Hospital/39
🇷🇺Vologda, Russian Federation
Tula Regional Clinical Hospital/21
🇷🇺Tula, Russian Federation
Yekaterinburg Regional Clinical Hospital #1
🇷🇺Yekaterinburg, Russian Federation
Sakhalin Regional Oncology Dispensary/32
🇷🇺Yuzhno-Sakhalinsk, Russian Federation